Robert F. Kennedy Jr. (left) and Mehmet Oz
SARASOTA, Fla. – A Florida wound care practice has sued federal health officials over a demand that it repay more than $2.1 million for treatments Medicare initially covered, alleging government reviewers misidentified the product used and improperly rejected evidence supporting its use.
Quantum Practitioner Services filed its complaint October 19 in U.S. District Court for the Middle District of Florida against the Department of Health and Human Services, the Centers for Medicare & Medicaid Services and their leaders, Robert F. Kennedy Jr. and Dr. Mehmet Oz. The Palmetto-based practice seeks to overturn an administrative ruling upholding the repayment demand and block what it describes as an unpublished policy of retroactively denying coverage for skin substitutes.
The dispute involves treatments provided to three Medicare beneficiaries between May and August 2023 using Dual Layer Impax Membrane, an amniotic tissue product applied to chronic wounds. Quantum says the patients had exhausted conventional wound care options and showed improvement after receiving the grafts.
Medicare initially paid the claims. Following a post-payment audit, however, contractor SafeGuard Services denied all 43 claims it reviewed, covering 73 service lines, and assessed an overpayment of about $2.25 million. First Coast Service Options, the Medicare administrative contractor, subsequently demanded repayment of $2,110,778.68 on May 8, 2024, according to the complaint. The filing does not explain the difference between those amounts.
The complaint describes administrative reviewers as questioning whether the treatments were medically necessary and whether sufficient evidence established the product’s safety and effectiveness. An independent contractor cited “insufficient support from double-blinded, randomized human clinical trials for safety and effectiveness” of Impax, according to the filing.
Quantum argues those decisions rested in part on a basic mistake: treating a solid membrane graft as an amniotic fluid product.
Administrative Law Judge Sean McKee upheld the denials in a July 15, 2025, decision, repeatedly describing Impax as an “amniotic fluid allograft,” the complaint says. Quantum contends that characterization led him to apply the wrong coverage analysis.
“It is not,” the complaint states. “Impax is a non-fluid amniotic membrane allograft — a solid tissue product — not a fluid-based product.”
The practice also alleges McKee improperly excluded medical literature submitted with its prehearing brief, then relied on a lack of supporting evidence to find the treatment experimental or investigational. Quantum says an expert report submitted earlier in the appeals process included a table of clinical studies, and the independent reviewer’s decision acknowledged receiving journal articles supporting the treatment.
Quantum, which is operated by advanced practice registered nurse Alexander Stephens, says the treatments met the coverage criteria in First Coast’s applicable local coverage policy.
The complaint identifies the patients only by their initials. One had foot and ankle wounds that had persisted for more than 20 years. Another used a wheelchair and had multiple chronic leg and foot wounds despite months of home health wound care. A third had diabetic foot ulcers that had not responded to treatments including intravenous antibiotics and hyperbaric therapy, according to the filing.
Quantum alleges some wounds closed and others decreased in size after treatment. Those descriptions are the practice’s allegations, not findings by the federal court.
Beyond challenging the individual denials, the lawsuit alleges federal contractors have adopted a broader, undisclosed practice of reopening previously paid skin-substitute claims and declaring the products experimental or investigational. Quantum argues the government imposed a new demand for product-specific clinical evidence without the notice and public comment required for changes to substantive Medicare payment standards. The complaint does not establish that such a policy exists; it asks the court to declare the alleged policy unlawful.
The practice appealed McKee’s decision to the Medicare Appeals Council in September 2025. After the council failed to act within the prescribed review period, Quantum sought escalation to federal court. The council granted that request August 20, 2026, according to the complaint.
The lawsuit raises three claims challenging the agency’s decision-making, its application of Medicare’s medical-necessity standard and its refusal to protect Quantum from repayment liability. As an alternative to finding the treatments covered, Quantum argues neither the practice nor its patients knew, or reasonably could have known, Medicare would refuse payment.
Quantum asks the court to reverse the administrative decision, order payment of the disputed claims, declare the practice free of repayment liability and award legal fees and costs as permitted by law. The supplied filing contains the plaintiff’s complaint, not a response from the defendants or a ruling on its allegations.
U.S. District Court for the Middle District of Florida case number 8:26-cv-03171
